L-HPC (low-substituted hydroxypropyl cellulose NF, JP, EP) This dual functioning excipient acts as both a disintegrant and binder. It is not the same as HPC. L-HPC is insoluble in water. It is an effective disintegrant due to its swelling action in water. Because is has good compressibility, it functions as a dry binder.L-HPC benefits are:Enhanced stability because it is non-ionic and has low water activityIt is peroxide free and provides excellent compatibility for oxygen sensitive APIsImproved disintegrationA variety of grades are available depending on the application. L-HPC LH-32 is suitable for wet granulation, pellet extrusion and layering.

Chemical Name: Low-Substituted Hydroxypropyl Cellulose

Manufacturing Technology: Direct Compression, Tablet Coating, Wet Granulation

Functions: Binder, Disintegrant

Labeling Claims: Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free

Certifications & Compliance: DMF Type IV, European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA)

    Knowde Enhanced TDS

    Identification & Functionality

    Pharma & Nutraceuticals Functions
    CAS No.
    9004-64-2
    EC No.
    618-388-0
    Structure

    L-HPC LH-32 - Structure

     

    Features & Benefits

    Features
    • Water insoluble, swells in water and works as dual functional ingredients, disintegrant and binder for tablets and pellets.
    • Suitable grade can be selected depending on process and API characteristics.
    • Non-ionic polymer which has less interaction with API and better stability.

    Applications & Uses

    Properties

    Physical Form
    Typical Properties
    ValueUnitsTest Method / Conditions
    Chloridemax 0.36%USP/NF
    Heavy Metalsmax. 0.001%USP/NF
    Hydroxypropoxy Content7.0 - 9.9%USP/NF
    Hydroxypropoxy Content8.0%-
    Loss on dryingmax. 5.0%USP/NF
    Particle MorphologyMicronized--
    pH5.0 - 7.5-JP
    Residue on ignitionmax. 0.5%USP/NF
    Particle Size Distribution
    ValueUnitsTest Method / Conditions
    Mean Particle Size20.0μm-
    Particle Size (90% cumulated)40 - 100μmShin-Etsu
    Particle Size (Average)17 - 23μmShin-Etsu
    Note

    *In-house Laser diffraction method

    Regulatory & Compliance

    Technical Details & Test Data

    Anti-Capping Effect of L-HPC

    L-HPC LH-32 - Anti-Capping Effect of L-Hpc

    Ethenzamide tablets were prepared with various ratio of excipients and friability test was implemented in accordance with USP method.

     

    Pictures of Aspirin Tablets with Various Excipients (After stability test)

    L-HPC LH-32 - Pictures of Aspirin Tablets With Various Excipients (After Stability Test)

    Aspirin tablets with 20% excipients were stored in closed plastic bottle at 50°C for 3 months.

     

    Packaging & Availability

    Packaging Type
    Package
    • 50 kg - Fiber drum with polyethylene double bag inside
    • 1 kg - Polyethylene double bag

    Storage & Handling

    Storage

    Keep dry. Store away from excess heat and sunlight. Store in sealed containers.